Ensuring the continued safety and performance of medical devices after they enter the market is a core responsibility for regulators worldwide.
In the United States, this function is led by the Food and Drug Administration (FDA) through the Center for Devices and Radiological Health (CDRH). In Europe, it is governed under the European Union Medical Device Regulation (EU MDR 2017/745), implemented jointly by national Competent Authorities, the European Commission, and Notified Bodies.
Post-Market Surveillance (PMS) plays a central role in ensuring that medical devices remain safe and effective after being made available on the market. While both FDA and the EU MDR impose robust PMS requirements, the scope, structure, and regulatory expectations differ significantly.
Discover how these two systems diverge — and what it means for manufacturers navigating obligations on both sides of the Atlantic.
Structure of the Post-Market Surveillance System
The FDA operates a centralised, federal post-market surveillance system. CDRH directly collects, analyses, and responds to safety information. The agency maintains national reporting mechanisms and can enforce corrections, conduct inspections, and mandate recalls. Manufacturers follow a PMS framework integrated into broader Quality System Regulation (QSR) requirements (21 CFR Part 820), soon transitioning into the Quality Management System Regulation (QMSR) aligned with ISO 13485.
The key elements of this system are complaint handling, Corrective and Preventive Actions (CAPA), Medical Device Reporting (MDR, a system which functions under the FDA and is distinct from the EU MDR, European Union Medical Device Regulations), corrections and removals reporting and post-market studies when ordered by FDA. The FDA does not require a unified PMS plan; surveillance is incorporated into quality and reporting systems.
Under EU MDR 2017/745, post-market surveillance (PMS) is decentralised, with manufacturers responsible for PMS planning while Competent Authorities (CAs) and Notified Bodies (NBs) provide oversight. The European Commission and Medical Device Coordination Group (MDCG) harmonise vigilance and surveillance across Member States.
EU MDR requires a formal, proactive PMS system (Articles 83–86) integrated with PMCF (Post-Market Clinical Follow-Up), risk management, clinical evaluation and a quality management system (Article 10). To comply, manufacturers must create a PMS Plan (Article 84; Annex III) and a PMS Report (Class I devices) or Periodic Safety Update Report (PSUR) (Class IIa/IIb/III devices).
_For a compressive breakdown of device classification, check out our previous article How EU device classification differs from the US - Are you Prepared?_
The key distinction is that the EU MDR requires a documented PMS system and recurring PMS reports while the FDA embeds PMS activities into QSR systems without mandating a specific PMS plan.
Vigilance Systems and Adverse Event Oversight
In alignment with 21 CFR Part 803, manufacturers with FDA-approved medical devices must report:
- Deaths or serious injuries (30-day reporting)
- Malfunctions that could cause serious harm if they recurred
- 5-day reports for events requiring immediate action
Manufacturers must maintain complaint files and evaluate whether events are MDR-reportable. FDA’s MDR focuses on reportable adverse events and malfunctions without trend analysis obligations.
EU MDR Articles 87 - 90 specify that manufacturers must report:
- Serious incidents
- Field Safety Corrective Actions (FSCA)
- Trend reporting for increases in non-serious incidents (Article 88)
Reporting timelines are stipulated for death or serious deterioration (maximum 10 days), serious threat to public health (2 days) or other serious incidents (15 days). The EU MDR also adds a requirement of trend reporting. Manufacturers must systematically monitor and report any statistically significant increase (“trend”) in non-serious incidents and expected undesirable side-effects. Although the statistical threshold is not defined, the manufacturer should base their chosen threshold on device type and intended purpose, expected incident rates, historical device performance, device population (indications, user groups) and device lifecycle stage (early vs. mature market).
Recalls, FSCAs and Corrections
Under 21 CFR Part 806, manufacturers must report certain corrections or removals made to reduce a health risk. They must conduct effectiveness checks during recalls and maintain a recall communication process.
EU MDR mandates that manufacturers must initiate Field Safety Corrective Actions (FSCA) when risks are identified. The manufacturer must generate an FSCA report detailing the reason for the FSCA, the root cause, the corrective action, the affected models and UDI-DI and the quantities placed on the market. This report is then uploaded via EUDAMED Vigilance Module, using standardised forms and workflows, to inform Competent Authorities. A Field Safety Notice (FSN) must be sent to users and customers to inform them of the FCSA and must also be uploaded to EUDAMED. EU MDR places greater emphasis on EU-wide coordination and therefore requires this structured FSCA communication.
Post-Market Clinical Evidence Requirements
The FDA may require manufacturers to perform targeted post-market studies for specific medical devices. Post-Approval Studies (PAS) for high risk Class III (PMA) devices (21 CFR 814.82) are required by the FDA to gather additional clinical, real-world, or long-term safety and effectiveness data once the device is in commercial use. Examples of such devices are cardiovascular implants, neuromodulation devices or combination products. These studies become part of the PMA approval order and are legally binding.
We have previously explored how devices are classified may also be different across both regulatory systems.
Additionally, 522 Post-Market Surveillance Studies for certain Class II and III devices (21 CFR Part 822) may be required by the FDA under certain circumstances such as recalls or complaints, identification of a potentially new hazard or if a risk signal arises from Medical Device Reports. Other than the examples stated above, routine post-market clinical evidence generation is not mandatory under the FDA.
EU MDR mandates Post-Market Clinical Follow-Up (PMCF) as part of a continuous evidence generation cycle (Annex XIV, Part B). It is required for almost all devices unless a manufacturer can justify that it is unnecessary. The EU MDR (Annex XIV Part B) does not dictate a single method; instead, manufacturers must choose PMCF activities proportionate to device risk, novelty, available evidence, and residual uncertainties. In general, higher-risk devices require more robust, clinically focused PMCF. PMCF should address any gaps found in the Clinical Evaluation such as lack of long-term data, limited patient diversity or underpowered endpoint in pre-market trials. In order to comply with these requirements, manufacturers must maintain a PMCF Plan, generate PMCF Evaluation Reports and incorporate results into the PMS and clinical evaluation process.
Summary
While both the FDA and the EU MDR aim to ensure the ongoing safety and performance of medical devices, their post-market surveillance frameworks differ in structure, rigor, and expectations. For medical device manufactures looking to expand their commercial reach into the European Union, understanding these distinctions is essential, not only for regulatory compliance but for designing post-market systems capable of supporting both proactive surveillance and robust, lifecycle-long clinical evidence.
Whether you’re preparing for EU market entry or seeking to optimise your post-market surveillance framework, our specialists can guide you every step of the way. Contact our team today.
